ImmuPharma PLC (LON:IMM) has started preparations for a new drug application of its lupus treatment Lupuzor with its Phase III trial now over half way through.
The AIM-listed group said the decision to start to manufacture commercial batches of Lupuzor was taken in anticipation of the trial's successful outcome and in consultation with its regulatory advisors.
READ: ImmuPharma says more than a quarter of patients have now completed Phase III lupus trial
Work is now underway on regulatory dossiers to support submissions to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).
The manufacturing process will be part of these submissions, the company said in a statement.
Application to be reviewed within 6 months of submission
All patients in the Phase III Lupuzor study have passed six months while 52 patients or 26% have now completed the full 12 months of the study.
Top line results are on schedule for the end of the first quarter next year.
Robert Zimmer, Immupharma’s chief scientific officer said: "We are delighted with the progress of the Lupuzor Phase III trial and are looking forward with confidence and planning for a successful outcome for the study.
“We are keen to ensure that there are no delays in submission to enable us to fully exploit our 'fast track' status, previously granted by the FDA, so that the company's package will be reviewed within 6 months of submission."